Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A Phase 2b Clinical Study to Evaluate the Safety and Efficacy of Topical Administration of Bacteriophage Therapy TP-102 in Patients with Diabetic Foot Infection

This research study is testing a new topical gel called TP-102 for people with diabetic foot infections. Diabetic foot infections are a serious problem where a common foot sore or ulcer becomes infected, often by bacteria like Acinetobacter baumannii, Pseudomonas aeruginosa, or Staphylococcus aureus. The study will compare TP-102 to a 'dummy' gel (called a placebo) and the usual care you would normally receive. Researchers want to find out if TP-102 is safe to use and if it can help the wounds heal better and faster. They will also be looking at how it affects the infection itself. This is a Phase 2 study, meaning it's an early stage of testing new treatments.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Technophage Investigacao E Desenvolvimento Em Biotecnologia S.A.

Enrolment target

Start

22 Jan 2024

Diabetic foot ulcers infected by Acinetobacter baumannii Pseudomonas aeruginosa and /or Staphylococcus aureus

What is this study about?

This study is about finding new and better ways to treat diabetic foot infections. If you have diabetes, sometimes a cut or sore on your foot can become infected. These infections can be tricky to treat, especially when caused by certain types of bacteria like those mentioned (Acinetobacter baumannii, Pseudomonas aeruginosa, and Staphylococcus aureus). The infection can make healing much harder.

The researchers are testing a new treatment called TP-102. This isn't a pill or an injection for your whole body; it's a special gel that you put directly onto the infected wound. They believe this gel might help fight off these specific bacteria and encourage the wound to heal. The study is comparing TP-102 to a 'placebo' gel, which looks exactly like TP-102 but doesn't contain the active ingredient, and also to the standard treatment you'd usually get for your infection.

The main things the doctors want to find out are whether TP-102 is safe (meaning it doesn't cause too many unwanted side effects) and if it works better than the placebo and standard care. They will also be closely watching how the wounds heal, checking for things like how much the wound area shrinks and if the infection clears up. This kind of research is very important because it could lead to new treatments that help people with diabetic foot infections heal faster and avoid more serious problems.

Key takeaways

This study tests a new gel, TP-102, for diabetic foot infections.
It aims to find out if TP-102 is safe and helps wounds heal better than usual care.
The treatment is applied directly to the infected wound.
Specific bacteria must be causing the infection for you to participate.
You might receive the active gel or a 'dummy' gel (placebo).

Who may be eligible?

This study is looking for adults who are at least 18 years old. Both men and women can take part.

To be eligible, you need to have a diabetic foot ulcer that has become infected. The doctors will also need to confirm that your infection is caused by specific types of bacteria: Acinetobacter baumannii, Pseudomonas aeruginosa, or Staphylococcus aureus.

There will be other detailed criteria that the study doctors will check to make sure the study treatment is suitable and safe for you. It's important to discuss your full medical history with them.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have diabetes?
Do you have an infected foot ulcer?
Has your doctor identified specific bacteria (Acinetobacter baumannii, Pseudomonas aeruginosa, or Staphylococcus aureus) causing the infection?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would likely have several visits to the clinic over a period of time. At these visits, doctors and nurses would perform various assessments to check your foot wound, monitor the infection, and record any changes. This might include taking measurements of your wound, reviewing your general health, and potentially taking samples from the wound.

You would receive either the active TP-102 gel or the placebo gel, applied to your wound, in addition to your usual standard care. You would be given instructions on how to apply the gel or if it will be applied by a healthcare professional. There would be regular checks for any side effects and to see how your wound is healing. The study involves a follow-up period after the main treatment has finished to see the long-term effects. The total duration of participation, including treatment and follow-up, would be fully explained by the study team.

Potential risks and benefits

Taking part in a study like this could offer potential benefits, such as receiving a new and potentially effective treatment for your diabetic foot infection that isn't yet widely available. You would also receive close medical attention and monitoring. However, there are potential risks, as with any new medicine. The gel might cause side effects like irritation at the application site. It's always possible that the treatment may not work for you, or that you might receive the placebo. Your safety will be closely monitored throughout the study. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Poland

Common questions

What is a 'diabetic foot infection'?

It's when a sore or wound on the foot of someone with diabetes gets infected by bacteria, making it harder to heal.

What is TP-102?

It's a new gel that's being tested to see if it can help treat these specific foot infections.

What does 'topical administration' mean?

It means the treatment is applied directly to the skin or the surface of the wound, not taken as a pill or injection.

What is a 'placebo'?

A placebo is a 'dummy' treatment that looks like the real treatment but doesn't contain any active medicine. It helps researchers see if the real treatment actually works.

What is 'standard care'?

This refers to the usual medical care and treatments you would normally receive for your condition, even if you weren't in the study.